The FDA Food Safety Modernization Act

The Biggest Impact to Food Safety Policy in Over 70 years

Richard H. Linton

Professor of Food Safety at Purdue University

On January 4, 2011, President Barack Obama signed into law a new federal statute called the FDA Food Safety Modernization Act (H.R. 2751). The FDA Food Safety Modernization Act is divided into four areas: prevention of food safety hazards, detection of and response to food safety problems, improving the safety of imported foods, and miscellaneous provisions. The new law provides greater authorization for the Food and Drug Administration (FDA) and the Secretary of Health and Human Services (HHS) to increase inspections of many domestic food facilities, enhance detection of foodborne illness outbreaks, and order recalls of contaminated food products. The new law requires most food companies to write and implement new safety protocols to control or eliminate potential foodborne hazards. More oversight of imported food products is also included in the law and more provisions are in place to deny entry of food products into the U. S. under certain circumstances.The FDA Food Safety Modernization Act is the most significant update of U.S. food safety laws since adoption of the U.S. Federal Food, Drug, and Cosmetic Act in 1938.

HHS will also require registration and payment of a fee by any person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports an article of food.Individuals who partake in food handling without official registration are subject to a maximum 10 year prison sentence. Registration requires each facility which produces or handles food to maintain records relating to food safety.The law contains an exception for food grown and consumed at private residences. Likewise, smaller farms that sell directly to consumers are exempt. For example, food sold at local farmers' markets would not be subject to the certification requirements.

Administratively detain food based only on a “reason to believe” the food is adulterated or misbranded.

Suspend the registration, and thereby suspend the operations, of any food facility if FDA determines that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Require that an article of food offered for import be accompanied by a safety certification from an accredited third-party auditor as an additional condition of granting admission.

Review relevant health data every two years and to issue guidance documents or regulations setting contaminant-specific performance standards for the most significant foodborne contaminants.

Establish a product tracing system to improve the agency’s capacity to effectively and rapidly track and trace food.

Under the FDA Food Modernization Act, there are several new regulatory requirements that follow:

Food facilities are required to register with FDA biennially.Food from an unregistered facility may not be imported into the United States or introduced into interstate or intrastate commerce.

Registered food facilities are required to conduct hazard analyses and to develop and implement written preventive control plans.

Registered food facilities must maintain additional records, including copies of their hazard analyses and preventive control plans, related records, and additional records to assist FDA in tracking and tracing high-risk foods.

Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.

Food facilities and food importers are subject to new fees, including a fee to be paid by each domestic food facility or importer that undergoes a re-inspection because of a material non-compliance identified during an initial inspection.

Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory, and lab test results must be sent directly to FDA.

Food facilities will be inspected with greater frequency and not less often than once every 5 years.

The Center for Disease Control and Prevention’s new estimates of foodborne illness in the U.S. each year total 47.8 million cases foodborne illnesses, 127,839 hospitalizations, and 3,037 deaths.This data suggest that about 1 in 6 people each year are afflicted by foodborne illness.This historic legislation that the President has signed directs FDA to work with a wide range of public and private partners to build a new system of food safety oversight – one focused on applying, more comprehensively than ever, the best available science and good common sense to prevent the problems that can make people sick.All food safety stakeholder groups will be eager to learn of the impact of the new food safety law.Because of the legislative process, overall implementation of the law is likely to take several years.

For more information about the FDA Food Modernization Act and new CDC foodborne illness statistics, go to the following websites listed below: